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Effects of Lutein and Zeaxanthin Supplementation on Age-related Macular Degeneration

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ClinicalTrials.gov Identifier: NCT01048476
Recruitment Status : Unknown
Verified March 2012 by Le MA, Peking University.
Recruitment status was:  Recruiting
First Posted : January 13, 2010
Last Update Posted : March 16, 2012
Sponsor:
Information provided by (Responsible Party):
Le MA, Peking University

Study Description
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Brief Summary:
Lutein is one of oxygenated carotenoids. Over the past few years, there has been increased interest in evaluating the effect of lutein for optimizing eye health. A large number of epidemiological studies support the notion that the high intake dietary of lutein is strongly associated with a decreased relative risk of AMD.Moreover, findings from initial observational studies have now been followed by placebo-controlled intervention trials showing that dietary modification and supplementation with lutein result in increasing the macular pigment optical density, and may help to improve visual function in patients suffering from AMD.Currently, nutritional status and background information of lutein and zeaxanthin in Chinese population is lack. Little is known about the preventive and therapy benefits of lutein on visual function in the AMD populations. In particular, the effect on visual function of relatively certain doses of lutein and zeaxanthin is unknown. Therefore, the objective of the present study was to examine the effect of consuming different doses of lutein on MPOD and visual function in AMD.

Condition or disease Intervention/treatment Phase
Age-related Macular Degeneration Dietary Supplement: lutein Dietary Supplement: Lutein Dietary Supplement: placebo Drug: Lutein and zeaxanthin Phase 1 Phase 2

Detailed Description:
We aim to study the effect and the mechanism of lutein in the prevention and treatment for age-related macular degeneration (AMD). Using the cluster sampling method, baseline characteristics screening will be performed in Han nationality men and women in the suburban areas of Beijing, ranging in age from 50 to79 years. According to clinical diagnosis standard of AMD, AMD (n=120) and normal subjects (n=40) will be randomly selected to measure serum lutein and nutritional status, and evaluate the relationship between lutein and AMD. Each subject of AMD will be randomly assigned to 1 of 4 groups: Group low lutein (Group LL); Group high lutein (Group HL); Group lutein/zeaxanthin (Group LZ); and Group Placebo to participate in the randomized, double-blind, placebo-controlled, 1 year intervention study, respectively. Macular pigment optical density,related symptoms and multifocal electroretinogram (mfERG) will be measured at at weeks 0, 24 and 48, to compare their dynamic changes in response to supplements at baseline and each follow-up visit, observe time- and dose-response correlation of supplementation with lutein, assess the efficacy, dosage of lutein and/or zeaxanthin supplement.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Lutein and Zeaxanthin Supplementation on Age-related Macular Degeneration
Study Start Date : September 2009
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Lutein

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group L20
Dietary Supplement: 20mg Lutein; daily supplementation one year
 Dietary Supplement: lutein
Dietary Supplement: 20mg Lutein; daily supplementation one year
Active Comparator: Group L10
Dietary Supplement: 10mg Lutein; daily supplementation one year
 Dietary Supplement: Lutein
Dietary Supplement: 10mg Lutein; daily supplementation one year
Placebo Comparator: Group Placebo
Dietary Supplement: Placebo, 0 mg Lutein
 Dietary Supplement: placebo
Dietary Supplement: placebo; daily supplementation one year
Active Comparator: Active Comparator: Group LZ
Dietary Supplement: 10mg Lutein and 10mg zeaxanthin; daily supplementation one year
 Drug: Lutein and zeaxanthin
Dietary Supplement: 10mg Lutein and 10mg zeaxanthin; daily supplementation one year


Outcome Measures
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Primary Outcome Measures :
  1. MPOD and multifocal electroretinograms [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. the safety and efficacy of lutein in reducing the risk of the development of advanced AMD. [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with nonexudative AMD (either categories 2, 3 or 4 according to the AREDS criteria; in group 4 the eyes with no-advanced AMD will be included)
  • Age between 50 and 90 years
  • Able to understand and comply with the requirements of the trial
  • Visual acuity > 0.4
  • Subjects must agree to take only the nutritional supplement that is

Exclusion Criteria:

  • Currently enrolled in an ophthalmic clinical trial
  • Eyes with concomitant macular or choroidal disorders other than AMD and with indefinite signs of AMD
  • Eyes with a diagnosis of exudative AMD with active subretinal neovascularization (SRNV) or CNV lesions requiring laser photocoagulation in the study eye
  • Subjects with significant ocular lens opacities causing vision decrease
  • Subjects with amblyopia
  • Subjects with optic nerve disease (neuropathy, atrophy, papilledema), unstable glaucoma as defined by intraocular pressures greater than 25 mm Hg, 3 or more glaucoma medications, C/D of 0.8 or greater and visual fields consistent with glaucoma; history of retina-vitreous surgery, degenerative myopia, active posterior intraocular inflammatory disease, chronic use of topical ocular steroid medications, vasoproliferative retinopathies (other than AMD), rhegmatogenous retinal detachment, and inherited macular dystrophies
  • Subjects with demand type pacemakers or epilepsy
  • Subjects with uncontrolled hypertension (defined as diastolic of 90 or greater and systolic of 150 or greater)
  • Subjects with recent history (within the previous year) of cerebral vascular disease
  • manifested with transient ischemic attacks (TIA's) or cerebral vascular accidents (CVA's)
  • Subjects with a history of AIDS
  • lutein supplementation within the last 3 months
  • Subjects who have had intraocular surgery in trial eye within 3 months prior to enrolling in the trial
  • Patients who are unwilling to adhere to visit examination schedules
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01048476


Locations
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China, Beijing
Peking university Recruiting
Beijing, Beijing, China, 100191
Contact: le Ma, MD       male@bjmu.edu.cn   
Sponsors and Collaborators
Peking University
More Information
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Responsible Party: Le MA, MAL, Peking University
ClinicalTrials.gov Identifier: NCT01048476    
Other Study ID Numbers: NSFC30872113
First Posted: January 13, 2010    Key Record Dates
Last Update Posted: March 16, 2012
Last Verified: March 2012
Keywords provided by Le MA, Peking University:
AMD
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases